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NEOPHARMTECH drives innovation through advanced technology and data-driven solutions. We focus on enhancing efficiency, precision, and continuous improvement to deliver excellence.
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BEeDC
Transforming BA/BE Study ExecutionBEeDC is an advanced end-to-end clinical software solution designed to streamline the entire study process, from participant screening to study completion. Developed specifically for Clinical Research Organizations (CROs), BEeDC ensures accurate, efficient, and compliant data management throughout the study lifecycle.
Challenges in BABE studies
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Regulatory Compliance & Documentation:
- Meeting stringent regulatory requirements (e.g., USFDA, EMA, CDSCO).
- Compliance to extensive documentation requirements.
- Multiple manual intraventions in each step.
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Data Accuracy & Integrity:
- Preventing manual errors and data inconsistencies.
- Extensive data entry and validations.
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Subject Recruitment & Retention:
- Identification and enrollement of suitable participants.
- Participation and protocol adherence.
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Complex Study Design & Protocol Deviations:
- Handling complex designs and multiple dosing regimens.
- Effective management of protocol deviations and amendments.
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Sample Management & Tracking:
- Ensuring correct labeling, storage, and tracking of samples.
- Managing sample integrity and chain of custody.
Our Solution
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Regulatory Compliance & Documentation:
- Automated Compliance: BEeDC ensures adherence to global regulatory requirements (USFDA, EMA, CDSCO) with built-in compliance controls.
- Audit Trails & e-Signatures: Complete traceability with secure audit trails and electronic signatures.
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Data Accuracy & Integrity:
- Real-Time Data Capture: Eliminates manual errors by capturing clinical and analytical data directly at the source.
- Centralized Database: Ensures single-source data truth and seamless data integrity.
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Subject Recruitment & Retention:
- Efficient participant Management: Tracks participant profiles, health history, and study participation.
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Complex Study Design & Protocol Deviations:
- Flexible Study Configurations: Supports complex crossover designs, dose adjustments, and amendments.
- Deviation Management: Automatically records and manages protocol deviations.
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Sample Management & Tracking:
- End-to-End Sample Tracking: Ensures traceability from collection to analysis with barcode/RFID integration.
- Chain of Custody Control: Ensures sample integrity and compliance.
Key Features & Benefits
End-to-End Study Management
Feature: Manages the entire BABE study lifecycle—from screening to report generation.
Benefit: Centralized control over entire workflows, reducing complexity.
Participant Management & Recruitment
Feature: Automates participant enrollment, screening, scheduling, and management.
Benefit: Reduces recruitment time and ensures effective subject management.
Regulatory Compliance & e-Signatures
Feature: Compliant with global regulatory standards (USFDA, EMA, CDSCO) with built-in audit trails and e-signatures.
Benefit: Ensures adherence to regulatory requirements, simplifies audits, and guarantees data authenticity.
Sample Management & Tracking
Feature: Barcode integration for sample collection, labeling, storage, and tracking.
Benefit: Prevents sample mix-ups and ensures traceability from collection to analysis.
Protocol & Deviation Management
Feature: Supports complex crossover designs, dosing regimens, and automated deviation management.
Benefit: Reduces protocol deviations and ensures accurate study execution.
Real-Time Data Capture & Integration
Feature: Captures real-time data directly from source systems.
Benefit: Eliminates manual errors, ensures data integrity, and speed up decision-making.
Why Choose BEeDC?
Enhanced Efficiency
Enhanced efficiency involves optimizing various aspects of data collection, processing, and compliance to ensure accuracy, reliability, and regulatory adherence.
Our approach to customer focus includes:
- Implement real-time validation checks (e.g., flagging duplicate or inconsistent entries).
- Regulatory Compliance
- Continuous Support & Improvement
- Collaborative Approach
Improved Accuracy
BEeDC (Bioequivalence Electronic Data Capture) software is designed to capture real-time activity data for BABE studies in CROs. Accuracy ensures regulatory compliance and data integrity.
Our commitment to reliability includes:
- Automated Time-Stamping
- Barcode Based
- Electronic Signature & Audit Trail
- Pre-defined Data Ranges
Regulatory Readiness
BEeDC ensures compliance with FDA, EMA, MHRA, CDSCO, and ICH by maintaining data integrity, security, and traceability.
Our approach to continuous improvement includes:
- Compliance with Regulatory Standards
- Role-Based Access Control & Security
- Integration with Other Systems
- Regulatory Submission Readiness
Scalable & Customizable
BEeDC's scalability and customizability ensure it fits varying CRO needs and study types.
Our approach to continuous support includes:
- Scalable to large datasets and study complexities
- Configurable Study Workflows
- Role-Based Access Control (RBAC)
- Custom Alerts & Notifications
- UI/UX Customization
Get Started
Neopharmtech India Private Limited
Madhava Nagar Colony,
Miyapur, Hyderabad, Telangana 500049